NHS hospitals risk being taken to court and sued for millions of pounds in the
future for carrying out genetic tests based on techniques patented by
private companies, it was warned yesterday.

At the moment they regularly infringe controversial DNA-based patents - for example to develop tests for relatively rare diseases like cystic fibrosis - with "tacit approval" from those in authority, say experts.

Many scientists believe patenting disease testing methods based on sections of DNA is inherently wrong, because it is close to patenting life itself. They also say it slows scientific innovation and reduces patient choice.

But biotech companies are becoming increasingly frustrated at not being paid for the fruits of their labours.

They believe they should be compensated for putting in the time and money to develop such tests. If they are not, they say there is little incentive to keep working in Britain.

Currently law suits over the intellectual property of DNA diagnostics are largely confined to the US, where lawyers are making huge sums picking over what is and is not an enforceable patent.

Related Articles

But court cases are becoming more and more likely here, said Michael Hopkins, an expert in the field from Sussex University.

He said: "As time goes on, it's more likely that a company will become hungry enough that they will want to pursue a hospital because they are infringing a test in a market that they very much value."

Right now he said the sums involved were relatively small, as many DNA-related patents involved testing for rare conditions. Consequently it was not worthwhile risking a costly court case.

But the stakes are rising. Increasingly, companies are applying for patents on DNA biomarker tests to screen whole populations for common diseases. Such cases could each be worth "millions", he said.

Dr Hopkins was speaking as the Human Genetics Commission published a report into the issue, which warned of a "profound tension" between the competing interests of private firms and NHS labs. It recommended better licensing guidelines.

Dr Stuart Hogarth, a researcher at King's College London with an interest in the area, said Britain could not continue "muddling through" like it had, with the Department of Health and politicians giving "tacit approval" for public sector labs to infringe patents.

There is fierce disagreement over the ethics of patenting DNA-based diagnostic tests.

Gail Norbury, a clinical scientist at Guy's Hospital in London, described them as "unacceptable, unenforceable and detrimental".

But Dr Berwyn Clarke, chief scientific officer of Lab21, a Cambridge-based diagnostic specialist, said if private companies had "no incentive to get their money back, they are not going to do the work in the first place".

In Europe DNA-related patent are generally only granted for specific testing methods on a small strip of DNA.

In the US it is easier, with companies claiming exclusive rights to test on larger parts of DNA.